Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description details a photometric chemical reaction for measuring inorganic phosphorus, with no mention of AI or ML terms or concepts.

Therapeutic

No.
The device measures inorganic phosphorus to aid in diagnosis and treatment, but it does not directly treat or prevent diseases.

Diagnostic

Yes
The device is described as being used to measure phosphorus (inorganic) which is "used in the diagnosis and treatment of various disorders." This explicitly states its role in diagnosis.

SaMD (Software as a Medical Device)

No

The device description clearly indicates a chemical reaction and photometric measurement, which requires physical reagents and a photometer, not just software.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use explicitly states that the device is "intended to measure inorganic phosphorus in serum, plasma and urine." These are biological samples taken from the human body.
Purpose: The measurements are used "in the diagnosis and treatment of various disorders." This directly aligns with the definition of an IVD, which is used to examine specimens derived from the human body to provide information for diagnostic purposes.
Method: The device uses a chemical reaction (inorganic phosphate reacting with molybdate) to analyze the sample, which is a common method for in vitro diagnostics.

The information provided clearly indicates that this device is used to perform tests on biological samples outside of the body to aid in diagnosis and treatment, which is the core function of an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The FOSFATEMIA UV AA test system is a device intended to measure inorganic phosphorus in serum, plasma and urine. Measurements of phosphorus (inorganic) are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance.

Product codes

CEO

Device Description

End point method.
Inorganic phosphate reacts with molybdate in the presence of acid to form a phosphomolybdate complex that is measured photometrically at 340 nm.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

ROCHE DIAGNOSTICS / BOEHRINGER MANNHEIM CORP. INORGANIC PHOSPHORUS test system

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 862.1580 Phosphorus (inorganic) test system.

(a)
Identification. A phosphorus (inorganic) test system is a device intended to measure inorganic phosphorus in serum, plasma, and urine. Measurements of phosphorus (inorganic) are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Summary

0

Image /page/0/Picture/1 description: The image is a black and white circular seal. The seal contains the text "Warner lab." around the top edge of the circle. Inside the circle are the words "ISO 9001" stacked on top of each other. Below that is the word "TUV" above the word "CERT", with two curved lines above and below the words "TUV" and "CERT".

NOV 1 6 2001

Image /page/0/Picture/3 description: The image shows the logo for Wiener lab. The logo consists of a stylized "W" inside of a circle on the left, followed by the text "Wiener lab." in bold, sans-serif font. Below the company name is the text "Especialidades para Laboratorios Clinicos" in a smaller font.

WIENER LABORATORIOS S.A.I.C. - Rishamba 2944 - 2008 Rosario - Argentina
Phone +54 (341) 432-9191/6 - Fax +54 (341) 432-5454/5555
Internet: http://www.wiener-lab.com.ar

Section 6 - Summary

510(k) Summary "This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21CFR 807.92"

y "The assigned 510(k) number is: _గం)3095

According to the requirements of 21 CFR 862.1580, the following Introduction information provides sufficient details to understand the basis of a determination of substantial equivalence.

Wiener Laboratorios S.A.I.C. 6-1 Submitter Riobamba 2944 Name, Address, 2000 - Rosario - Argentina Contact Tel: 54 341 4329191 Fax: 54 341 4851986 Contact person: Viviana Cétola Date Prepared: July 25, 2001
Proprietary name: Wiener lab. FOSFATEMIA UV AA 6-2 Device Name

Common name: Phosphorus (inorganic) test system

Classification name: Phosphomolybdate (Colorimetric), Inorganic Phosphorus, CEO, as per 21 CFR section 862.1580.

Device Class I

1

| 6-3 Predicate
Device | We claim substantial equivalence to the currently marketed
ROCHE DIAGNOSTICS / BOEHRINGER MANNHEIM CORP.
INORGANIC PHOSPHORUS test system (Cat. Nº 836281) |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 6-4 Device
Description | End point method. |
| | Inorganic phosphate reacts with molybdate in the presence of
acid to form a phosphomolybdate complex that is measured
photometrically at 340 nm. |
| 6-5 Intended Use | The FOSFATEMIA UV AA test system is a device intended to
measure inorganic phosphorus in serum, plasma and urine.
Measurements of phosphorus (inorganic) are used in the
diagnosis and treatment of various disorders, including
parathyroid gland and kidney diseases, and vitamin D
imbalance. |
| and Differences | 6-6 Equivalencies The Wiener lab. Inorganic Phosphorus test system is
substantially equivalent to other products in commercial
distribution intended for similar use. Most notably it is |

distribution intended for similar use. Most substantially equivalent to the currently marketed ROCHE DIAGNOSTICS / BOEHRINGER MANNHEIM CORP. INORGANIC PHOSPHORUS test system.

The following table illustrates the similarities and differences between the Wiener lab. Inorganic Phosphorus test system and currently marketed ROCHE DIAGNOSTICS / the the BOEHRINGER PHOSPHORUS test system.

| ROCHE/BOEHRINGER
Test System | WIENER LAB.
Test System | |
|------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|
| Intended Use | Method for measurement of inorganic phosphorus. | |
| | ROCHE/BOEHRINGER
Test System | WIENER LAB.
Test System |
| Test Principle | End point method.
Inorganic phosphate reacts with molybdate in the
presence of sulfuric acid to form a
phosphomolybdate complex that is measured
photometrically at 340 nm. | |
| Essential
Components | Ammonium molybdate - Sulfuric acid | |
| Reagents | R1: Sulfuric acid and
detergent.
R2: Sulfuric acid, Ammonium
molybdate and Sodium
chloride. | R: Sulfuric acid and
Ammonium molybdate. |
| Instability or
Deterioration
of Reagents | Not specified | Absorbance of
Reagent > 0.500. |
| Working
Temperature
Range | 25 – 37°C | |
| Stability of
Final Color | Not specified | 20 minutes |
| Wavelength of
Reading. | 340 nm | |
| Calibration | Single point | |
| Linearity | 20 mg/dl | 16 mg/dl |
| Minimum
Detection
Limit | Not specified | 0.11 mg/dl |

2

and the same of the state of the county of

3

6-7 Conclusion Above mentioned data show substantial equivalency to the predicate device.

4

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is positioned to the right of the text, which is arranged in a circular pattern around the symbol. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)".

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

NOV 1 6 2001

Dr. Viviana Cétola QC/QA Manager Wiener Laboratorios S.A.I.C. 2944 Riobamba Rosario, Santa Fe Argentina

Re: K013095

Trade/Device Name: Wiener Lab. Fosfatemia UV AA Test System Regulation Number: 21 CFR 862.1580 Regulation Name: Phosphorus (inorganic) Test System Regulatory Class: I Product Code: CEO Dated: August 13, 2001 Received: September 17, 2001

Dear Dr. Cétola:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

5

Page 2 -

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and 1 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device. please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrb/dsma/dsmamain.html".

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

6

CDRH ODE

K013095.

NOV 1 6 2001

| 8
ge
C
C | C
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |

-------------------	-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

510(k) Number (if known):	K013095
Device Name:	Wiener lab.
	Fosfatemia UV AA

Indications For Use:

The "Wiener lab. Fosfatemia UV AA" test system is a quantitative in vitro diagnostic device intended to measure inorganic phosphorus in serum, plasma and urine. Measurements of phosphorus (inorganic) are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance.

(Division Sign-Off)
Division of Clinical Labo	Aces
510(k) Number	K013095

RECEIVED

FDA/CORE/ODE/C

SEP 17 12 20 PM 0.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEBORD)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use بـ

(Optional Format 1-2-96)

SK26